USFDA's "official action indicated" given to Jubilant Generics Ltd's Roorkee facility

31 Oct 2022 , 09:51 AM

Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Pharma Limited, has announced that its subsidiary Jubilant Generics Limited (JGL) received a communication from the USFDA through which the latter intimated that pursuant to its July-Aug 2022 audit of JGL’s Solid Dosage Manufacturing facility at Roorkee it has determined inspection classification of the facility as “official action indicated”.

As per the filing, the Company currently supplies one product to US market that contributes low- single digit revenue to Jubilant Pharmova revenues

“The Company has been continuously cooperating with the USFDA and will undertake all necessary steps to resolve regulatory status at the Roorkee facility”, Jubilant Pharmova said.

At around 9:50 AM, Jubilant Pharmova was trading at Rs387.35 per share higher by 4.38% as against previous closing of Rs371.10 per share on the BSE.

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